Here is the information regarding the DR2000 registration with US FDA.
DR2000 itself is a 510(k)-exempt product, therefore it does not have its own 510(k).
More specifically, DR2000 is regulated as a repackaged kit containing three medical device components. Therefore, to register DR2000 with FDA, Microtek - the entity responsible for performing the repackaging - has registered as a repackager under each of the three medical device components, shown below:
Device Component | Product Code | Microtek Registration |
Lithotomy Drape | EYY |  |
TRUS Probe Cover | IYO |  |
AquaBeam Robotic System Drape Set (equipment drapes) | PUI |  |
Link to original Ticket from RA: